
Sime Health, Ltd.
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AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI is an FDA 510(k)-cleared medical device (K932985) manufactured by Sime Health, Ltd.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 1995. Regulation: 8.

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